Myocardial Dysfunction Evaluation in Lower Extremity Arte... | NCT06215248

Studies
Myocardial Dysfunction Evaluation in Lower Extremity Arterial Disease Patients With Deformation Analysis

NCT06215248

Sponsor

Tartu University Hospital

Status

Recruiting

Last Update Posted

Dec 16, 2025Actual

Enrollment

162Estimated

Phase

Not provided

Conditions

Peripheral Artery Disease
Heart Failure

Interventions

Not provided

Countries

Estonia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2024Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Jan 10, 2024

First Submission Date that Met QC Criteria

Jan 10, 2024

First Posted Date

Jan 22, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2025

Last Update Posted Date

Dec 16, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Single centre observational study to assess lower extremity arterial disease (LEAD) patients' cardiac dysfunction with strain analyses and to assess connections between cardiac dysfunction, metabolomic changes and target organ damage in LEAD.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

162Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LEAD		LEAD diagnosis confirmed by by ankle-brachial index (≤0,9 or >1,3) or angiography. Fontaine I-IV class symptoms.
Controls		Matched with LEAD group's patients as much as possible for age, sex, smoking history, hypertension, diabetes, coronary artery disease.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
left ventricular global longitudinal strain (GLS)	assessed by deformation analysis with echocardiography	after enrollment and one year later

Secondary Outcomes

Measure	Description	Time Frame
other echocardiographic parameters	left ventricular ejection fraction, left atrial strain, lateral, medial and averaged E/E', left atrial volume, maximal tricuspid regurgitation velocity, right ventricular strain	after enrollment and one year later
heart failure diagnosis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria in LEAD group:

Fontaine I-IV class symptoms
Confirmed diagnosis of LEAD

Inclusion Criteria in control group:

Age 35-85
Has to have at least of the following: hypertension, diabetes, coronary artery disease or the patient smokes

Exclusion Criteria:

Age <35 or >85 years
BMI ≥40 kg/m²
Known heart failure in history
Any acute or chronic autoimmune or rheumatic disease
Cardiac structural disease in history: inflammatory, infiltrative diseases, nonischemic cardiomyopathies
Acute coronary syndrome in last 3 months
Moderate to severe cardiac valvular disease
Cardiac valvular disease operative/invasive treatment in history
Cardiac implantable electronic device (CIED)
Transitory ischemic attack or stroke in last 3 months
Severe COPD (GOLD C or D)
Moderate to severe asthma (according to GINA 2022 criteria)
Untreated hypertension (noninvasive blood pressure measurement ≥180/110 mmHg during recruitment)
Chronic severe kidney dysfunction (eGFR <30 ml/min/1,73 m²)
Malignant tumor with radiation treatment to thorax, oncologic or biologic treatment in history
Chronic hematologic disease (except for anemia)
Severe liver dysfunction
Malignant tumor with <5 years of remission
Acute or chronic infectious disease
Anemia with hemoglobin <80 g/L

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with cardiovascular risk factors

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Jaak Kals, PhD	Contact	731 8292	+372	jaak.kals@ut.ee

Name	Affiliation	Role
Jaak Kals, PhD	Tartu University Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Tartu University Hospital	Recruiting	Tartu			Estonia

Label	URL
Endothelial Research Centre	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058729	Peripheral Arterial Disease
D006333	Heart Failure

Ancestor Terms

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

Browse Leaves

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Browse Branches

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